THE EFFECT OF PROLIVERENOL SUPPLEMENTATION ON LIVER FUNCTION IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD)
Tahapan Penelitian : Complete
Sponsor:
PT Dexa Medica
Mitra Pelaksana:
PT Equilab International
No Registry
INA-44YO6M48
Tanggal Input Registry : 25-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 28-04-2024 |
| Outcome Primer | To investigate the efficacy of Proliverenol bioactive fraction in improving liver function of patients with non-alcoholic fatty liver disease (NAFLD) |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | THE EFFECT OF PROLIVERENOL SUPPLEMENTATION ON LIVER FUNCTION IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD) |
| Judul Penelitian Ilmiah | THE EFFECT OF PROLIVERENOL SUPPLEMENTATION ON LIVER FUNCTION IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD) |
| Jenis Penelitian | Interventional |
| Intervensi | The product to be investigated is bioactive fraction proliverenol film-coated caplet @ 500 mg (Veprolin) |
| Jumlah Subyek Penelitian | 80 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Signed informed consent from the patients or patients’ legally acceptable representatives (must be obtained before any trial related activities), Male or female subjects with age of ≥ 18 years at screening, Diagnosed as NAFLD (ranging only from steatosis to NASH, nonalcoholic steatohepatitis) as supported by the presence of increased echogenicity (“bright” scan) with liver ultrasonography (USG). Patients with bright liver appearance based on USG, will be followed by CAP examination, Steatosis is defined if CAP >263 dB/m, Presence of hepatic impairment, defined as any of serum ALT level > ULN, Able to take oral medication, Patients or patients’ legally acceptable representatives are able and willing to record adverse events in a diary, Patients or patients’ legally acceptable representatives have the ability to comply with the trial protocolExclusion Criteria: Suspected positive COVID-19 based on clinical symptoms or SARSCOV-2 antigen test, pregnant and lactating women, suspected alcoholic liver disease based on medical history, history of or presence of autoimmune liver disease, presence of bilirubin level >2x ULN, uncontrolled diabetes melitus with HbA1c >9%, current use of antidiabetic except metformin or sulfonylurea, history of or presence of significant or advanced heart disease, history of stroke the past 6 months prior to screening, medical history of thyroid disease, patients with HIV/AIDS |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-255/UN2.F1/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Vicky Achmad Ginanjar |